Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344617
Status:
UNKNOWN
Last Update Posted:
2007-09-26
First Post:
2006-06-23
Brief Title:
Off-Label AVASTIN BEVACIZUMAB For Serosanguinous Maculopathy
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
Off-Label Use of AVASTIN BEVACIZUMABIntravitreal Injection For the Treatment of Serosanguinous Maculopathy
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the use of Avastin for the management of serosanguinous maculopathy
Detailed Description:
METHODOLOGY
Patients will be recruited from the vitreoretinal clinics at SNEC After initial assessment clinically and angiographically the patient will be counselled with regards to diagnosis prognosis and management options including the option of intravitreal Avastin
Inclusion criteria
1 All subfovealjuxtafoveal CNV and PCV polypoidal choroidal vasculopathy who are not eligible for other treatment options compassionate use
2 CNV and PCV lesions which have failed PDT conventional argon laser photocoagulation salvage use
3 CNV and PCV lesions treatable with PDT but cannot afford or refused
Exclusion criteria
1 Patients with uncontrolled hypertension systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
2 History of thrombolic events such as myocardial infarction or cerebral vascular accident
3 Renal abnormalities as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis
4 Recent as defined as the past 28 days or planned as defined as the next 3 months surgery
5 Coagulation abnormalities including anti-coagulant medication other than aspirin
6 Patients with peptic ulcer disease
7 Pregnant or lactating females
If the patient is agreeable to the intravitreal treatment protocol heshe will be assessed systemically for fitness for the therapy The serosanguinous maculopathy will be subtyped by angiographic findings to predominantly classic 50 classic component lesions minimally classic 50 classic component lesions occult lesions and polypoidal choroidal vasculopathy PCV
If the patient is eligible for the intravitreal treatment protocol heshe will receive 1mg of Avastin intravitreally This will be performed under aseptic technique See attached Intravitreal Injection Protocol The injections will be repeated every 8-10 weeks for a total of 3 treatments
END OF TREATMENT
If the central retinal thickness is reduced by 50 or if there is imrpovementstablisiation of vision or if an adverse effect such as elevation of BP is encountered the treating physician can elect to withhold the Avastin treatment
On review at the 8 and 16 weeks the physician can elect to perform additional intravitreal Avastin treatment if any of the following should arise
1 Loss of VA of at least 5 letters at 2 sequential visits within 2 weeks which is associated with increased leakage from the CNV seen on angiography or OCT
2 Increase in OCT central retinal thickness by 100um
3 Onset of a new macular haemorrhage
4 Development of a new classic CNV membrane
5 Ocular outcome measurements
6 Change from baseline in VA ie gain or loss of 5 letters 1 line 15 letters 3 lines or 30 letters 6 lines
Secondary outcomes
1 Change in OCT measured central retinal thickness
2 Correlation in change in central retinal thickness and change in VA
Once informed consent has been obtained for intravitreal Avastin therapy the patient will be assessed for the fitness to indergo the treatment Baseline systemic ocular assessments will be performed Systemic assessment will include blood pressure measurement electrocardiogram ECG and blood investigations full blood count prothrombin time partial thromboplastin time bleeding time
Once deemed fit the patient will receive Injection 1 of intravitreal Avastin Refer Intravitreal Injection Protocol
The patient will then be reviewed at 1 week post-injection and then monthly for the first 2 months Investigations at these visits will include logMAR BCVA biomicroscopy FFA and OCT
At the time point of 8-10 weeks the patient will undergo Injection 2 Followed by review at 1 week post-injection and monthly for 2 months with the same investigations as stated above
At 16-20 weeks the patient will receive the last treatment Injection 3 with similar post-injection visits and investigations
If the central retinal thickness is reduced by 50 or if there is imrpovementstablisiation of vision or if an adverse effect such as elevation of BP is encountered the treating physician can elect to withhold the second andor third Avastin treatment Hence each patient will receive at least 1 injection of Avastin and up to a maximum of 3 injections
Patients will be recruited from the vitreoretinal clinics at SNEC After initial assessment clinically and angiographically the patient will be counselled with regards to diagnosis prognosis and management options including the option of intravitreal Avastin
Inclusion criteria
1 All subfovealjuxtafoveal CNV and PCV polypoidal choroidal vasculopathy who are not eligible for other treatment options compassionate use
2 CNV and PCV lesions which have failed PDT conventional argon laser photocoagulation salvage use
3 CNV and PCV lesions treatable with PDT but cannot afford or refused
Exclusion criteria
1 Patients with uncontrolled hypertension systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
2 History of thrombolic events such as myocardial infarction or cerebral vascular accident
3 Renal abnormalities as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis
4 Recent as defined as the past 28 days or planned as defined as the next 3 months surgery
5 Coagulation abnormalities including anti-coagulant medication other than aspirin
6 Patients with peptic ulcer disease
7 Pregnant or lactating females
If the patient is agreeable to the intravitreal treatment protocol heshe will be assessed systemically for fitness for the therapy The serosanguinous maculopathy will be subtyped by angiographic findings to predominantly classic 50 classic component lesions minimally classic 50 classic component lesions occult lesions and polypoidal choroidal vasculopathy PCV
If the patient is eligible for the intravitreal treatment protocol heshe will receive 1mg of Avastin intravitreally This will be performed under aseptic technique See attached Intravitreal Injection Protocol The injections will be repeated every 8-10 weeks for a total of 3 treatments
END OF TREATMENT
If the central retinal thickness is reduced by 50 or if there is imrpovementstablisiation of vision or if an adverse effect such as elevation of BP is encountered the treating physician can elect to withhold the Avastin treatment
On review at the 8 and 16 weeks the physician can elect to perform additional intravitreal Avastin treatment if any of the following should arise
1 Loss of VA of at least 5 letters at 2 sequential visits within 2 weeks which is associated with increased leakage from the CNV seen on angiography or OCT
2 Increase in OCT central retinal thickness by 100um
3 Onset of a new macular haemorrhage
4 Development of a new classic CNV membrane
5 Ocular outcome measurements
6 Change from baseline in VA ie gain or loss of 5 letters 1 line 15 letters 3 lines or 30 letters 6 lines
Secondary outcomes
1 Change in OCT measured central retinal thickness
2 Correlation in change in central retinal thickness and change in VA
Once informed consent has been obtained for intravitreal Avastin therapy the patient will be assessed for the fitness to indergo the treatment Baseline systemic ocular assessments will be performed Systemic assessment will include blood pressure measurement electrocardiogram ECG and blood investigations full blood count prothrombin time partial thromboplastin time bleeding time
Once deemed fit the patient will receive Injection 1 of intravitreal Avastin Refer Intravitreal Injection Protocol
The patient will then be reviewed at 1 week post-injection and then monthly for the first 2 months Investigations at these visits will include logMAR BCVA biomicroscopy FFA and OCT
At the time point of 8-10 weeks the patient will undergo Injection 2 Followed by review at 1 week post-injection and monthly for 2 months with the same investigations as stated above
At 16-20 weeks the patient will receive the last treatment Injection 3 with similar post-injection visits and investigations
If the central retinal thickness is reduced by 50 or if there is imrpovementstablisiation of vision or if an adverse effect such as elevation of BP is encountered the treating physician can elect to withhold the second andor third Avastin treatment Hence each patient will receive at least 1 injection of Avastin and up to a maximum of 3 injections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None